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All cancer screening tests generate both false-positive and false-negative results, with a tendency to yield more false positives. [10] False-negative tests may provide a false sense of reassurance, possibly leading to a bad prognosis if the cancer is diagnosed at a later stage, despite the utilization of surgeries, therapies, and other treatments.
The company reported $1.43 billion in revenue last year from its screening business, primarily from sales of its colon cancer test Cologuard, which was approved by the FDA in 2014.
Top-Line Data Show Exact Sciences' Cologuard Test Demonstrates 92 Percent Sensitivity in the Detection of Colorectal Cancer All endpoints achieved in 10,000-patient trial of non-invasive ...
The guaiac test can often be false-positive which is a positive test result when there is in fact no source of bleeding. This is particularly common if the recommended dietary preparation is not followed, as the heme in red meat or the peroxidase or catalase activity in vegetables, especially if uncooked, can cause analytical false positives.
Exact Sciences Corp. is an American molecular diagnostics company based in Madison, Wisconsin specializing in the detection of early stage cancers. The company's initial focus was on the early detection and prevention of colorectal cancer; in 2014 it launched Cologuard, the first stool DNA test for colorectal cancer.
The Cologuard Plus test is now approved for adults ages 45 and older who are at average risk for colorectal cancer (CRC). FDA approval was based on findings from the pivotal BLUE-C study, one of ...
The false positive rate (FPR) is the proportion of all negatives that still yield positive test outcomes, i.e., the conditional probability of a positive test result given an event that was not present. The false positive rate is equal to the significance level. The specificity of the test is equal to 1 minus the false positive rate.
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